scholarly journals Pharmacokinetic Comparability of Risankizumab Formulations in Prefilled Syringe and Auto-injector for Subcutaneous Injection

2021 ◽  
Author(s):  
Hoi-Kei Lon ◽  
Ling Cheng ◽  
Sai Nudurupati ◽  
Ralf Loebbert ◽  
Rachel Duan ◽  
...  
Keyword(s):  
Subcutaneous Injection ◽  
Prefilled Syringe ◽  
Pharmacokinetic Comparability ◽  
Auto Injector

scholarly journals Epinephrine auto-injector needle length

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Sten Dreborg ◽  
Gina Tsai ◽  
Harold Kim
Keyword(s):  
Drug Delivery ◽  
High Pressure ◽  
Children And Adolescents ◽  
Subcutaneous Injection ◽  
Low Pressure ◽  
Ultrasound Probe ◽  
Needle Length ◽  
Upper Limits ◽  
Auto Injector ◽  
Intramuscular Delivery

Abstract Background Epinephrine auto-injectors are expected to deliver the drug intramuscularly. Objective To study whether injection through clothing influences the frequency of subcutaneous and intraosseous/periosteal deposition of epinephrine. Methods Skin to muscle and skin to bone distances were measured for 303 children and adolescents and 99 adults. Distance was determined by ultrasound, with high or low pressure on the ultrasound probe. The risk/percentage of subcutaneous and intraosseous/periosteal injections was calculated using the lower and upper limits for the authority-approved length of EAI needles as provided by two high pressure EAI manufacturers and one low pressure EAI manufacturer. The addition winter clothing on the delivery of epinephrine was illustrated by comparing drug delivery fissue depth with no clothes. Furthermore, the riof non-intramuscular delivery for the shortest and longest approved needle length was calculated. Results When using EpipenJr® in children < 15 kg the risk of intraosseous/periostal injection was reduced from 1% and 59% for the shortest and longest approved needle length to 0 and 15% with winter clothes. The Auvi-Q® 0.1 mg had no risk of intraosseous/periosteal injection. However, the subcutaneous deposition risk increased from 94% and 28% to 100% and 99% with winter clothes. The risk of subcutaneous injection using EpipenJr® in the youngest children increased from 13% and 0% to 81% and 1% with winter clothes, and with Epipen® in adults from 45% and 17% to 60% and 38%. Emerade®, had a risk of subcutaneous injection in adults increasing from 14% and 10% to 28% and 21% adding winter clothes. Conclusion The risk of intraosseous/periosteal injections decreases and the risk of subcutaneous injection increases when injecting through winter clothes for all EAIs.

scholarly journals A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jim Bush ◽  
Kazuki Kawakami ◽  
Rafael Muniz
Keyword(s):  
Healthy Subjects ◽  
Safety Concern ◽  
Relative Bioavailability ◽  
Open Label ◽  
Single Dose Study ◽  
Prefilled Syringe ◽  
Concentration Time ◽  
Disposable Syringe ◽  
Dose Study ◽  
Auto Injector

Abstract Background/objective FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), in healthy subjects. Methods This randomized, open-label, parallel-group, single SC-dose study was conducted in 195 healthy male and female subjects who were randomized 1:1:1 to receive FKB327 40 mg via PFS, AI, or vial. The primary pharmacokinetic (PK) parameters, areas under the serum concentration-time curve to the last detectable value (AUC0-t) and extrapolated to infinity (AUC0-∞), and maximum concentration (Cmax), were compared. Relative bioavailability was established if the ratio of geometric least squares (LS) means of the test product was within the predefined bioequivalence (BE) range of 0.80 to 1.25 of the RP for each comparison. Safety and immunogenicity were assessed. Results The mean serum FKB327 concentration-time profiles appeared similar across all 3 presentations. AUC0-t, AUC0-∞, and Cmax were within the predefined BE range for PFS compared with vial, suggesting comparable bioavailability. AUC0-∞ and Cmax of AI compared with vial and PFS were fully contained within BE range, although the upper limit of 90% confidence intervals of the geometric LS means ratios for AUC0-t was slightly high. Treatment-emergent adverse events in all 3 groups were mild, with no new safety concern with FKB327 identified. Similar immunogenicity was observed among administrations. Conclusion Among all 3 delivery methods, PK characteristics, safety profiles, and immunogenicity were similar. Trial registration EU Clinical Trials Registry EudraCTN2014–004469-26, registered October 14, 2014.

scholarly journals Epinephrine Auto-Injector Needle Length (Does Height or BMI add Valuable Information in Adults?)

2019 ◽  
Vol 7 (1) ◽  
pp. 6-19
Author(s):  
Sten Dreborg ◽  
◽  
Gina Tsai ◽  
Harold Kim
Keyword(s):  
High Pressure ◽  
High Risk ◽  
Predictive Value ◽  
Subcutaneous Injection ◽  
Obese Women ◽  
Obese Adults ◽  
Overweight Women ◽  
Increased Risk ◽  
Injection Methods ◽  
Auto Injector

Background: Some overweight and obese adults have an increased risk of subcutaneous injection using epinephrine auto injectors (EAIs). Needle lengths of EAIs vary between brands and lots. Objective: To study if BMI or height adds information to define adults at risk of having intraosseous or subcutaneous injection. Methods: Ninety-nine (99) food allergic adult patients, 32 men and 67 women, 18 – 72 years of age, prescribed EAIs were included. The skin to muscle and skin to bone distances were measured by ultrasonography. The effect of injection on naked skin or through thick clothing was analyzed. High and minimal pressure was applied to the ultrasound probe. Results: Two of three men and 1/5 women with BMI <20 had a risk of intraosseous/periosteal injection using the high pressure auto injector Epipen® , thick clothing, 5/8. Injecting through naked skin using the shortest needle, 14/17 obese women had a high risk of subcutaneous injection (overweight 14/23), through thick clothing all 17 obese women would have a risk of subcutaneous injection (overweight 20/23). Injecting with LPEAIs through naked skin, using the shortest needle 8/17 obese and 4/23 overweight women would have a risk of subcutaneous injection, wearing thick clothing, 10/17 obese and 7/23 overweight women. Height had no predictive value. Conclusion: Using high pressure EAIs, high BMI predicted a very high risk for subcutaneous injection in women and in some men. Even injection with low pressure EAIs had some risk of subcutaneous injection, especially when injected through thick clothing. Height had no predictive value. Keywords: Auto-injector; epinephrine; intramuscular; subcutaneous; intraosseous; skin to bone distance; skin to muscle distance; clothing; overweight; obese; adults; women; men.

scholarly journals Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA

2020 ◽  
Author(s):  
Justyna Roszkiewicz ◽  
Zbigniew Swacha ◽  
Elzbieta Smolewska
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Side Effects ◽  
Subcutaneous Injection ◽  
Pediatric Population ◽  
Ease Of Use ◽  
Rank Test ◽  
Drug Bioavailability ◽  
Prefilled Syringe ◽  
Signed Rank ◽  
Signed Rank Test

Abstract BACKGROUND: Methotrexate is the most commonly used disease-modifying antirheumatic drug recommended in the treatment of juvenile idiopathic arthritis. It can be administered orally or subcutaneously, the latter method is associated with fewer side effects and higher drug bioavailability. Nevertheless, the pain associated with injection is a considerable drawback of this treatment option in the pediatric population. Currently, there are two single-use subcutaneous injection devices available: the prefilled syringe and the prefilled pen. This prospective, two-sequence crossover study aimed to compare ease of use, frequency of therapy side effects, injection-site pain and parent/patient preference of those methotrexate parenteral delivery systems.METHODS: 23 patients with juvenile idiopathic arthritis, already treated with subcutaneous methotrexate in the form of prefilled syringe in the period October 2018 – April 2019 completed a questionnaire evaluating their experience with this device. Subsequently, children received a one-month supply of pen autoinjector and completed the same questionnaire, regarding their experience with the new methotrexate delivery system. If the patient was not performing the injections himself the questionnaires were completed by the caregiver administrating MTX. The results obtained in both questionnaires were compared using the Wilcoxon matched-pairs signed-rank test.RESULTS: 82,6% patients and their caregivers voted for the prefilled pen as their preferred method of subcutaneous methotrexate administration. Moreover, the injection with the prefilled pen was reported as less painful in comparison to the prefilled syringe (p<0.01). Side effects of methotrexate were less pronounced after the prefilled pen treatment, this difference was most prominent regarding gastrointestinal adverse events associated with the injection (p<0.01).CONCLUSION: Administration of methotrexate using the pen device is a promising way of subcutaneous methotrexate delivery in children with juvenile idiopathic arthritis, as the injection is less painful and associated with fewer side effects.

scholarly journals Subcutaneous Injection Performance in Yucatan Miniature Pigs with and without Human Hyaluronidase and Auto-injector Tolerability in Humans

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Galen H. Shi ◽  
Robert J. Connor ◽  
David S. Collins ◽  
David W. Kang
Keyword(s):  
Injection Site ◽  
Subcutaneous Injection ◽  
Therapeutic Agents ◽  
Injection Time ◽  
Miniature Pigs ◽  
Recombinant Human Hyaluronidase ◽  
Auto Injector ◽  
Over Time

AbstractRecombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous (SC) delivery of co-administered therapeutic agents by locally and transiently degrading hyaluronan in the SC space, and can be administered with therapeutics using a variety of devices. Two SC delivery studies were carried out to assess auto-injector (AI) performance, each in 18 Yucatan miniature pigs. Abdominal injections were administered using three auto-injectors of 1 mL (AI1) and 2 mL (AI2 and sAI2) with different injection speeds and depths (5.5–7.5 mm) and two pre-filled syringe (PFS) devices of 1 and 2 mL. The injection included a placebo buffer with and without rHuPH20 to evaluate the effect of rHuPH20 on SC injection performance. The feasibility of using similar devices to deliver a placebo buffer in humans was investigated. rHuPH20 was not studied in humans. In miniature pigs, postinjection swelling was evident for most PFS/AI injections, particularly 2 mL. Swelling heights and back leakage were typically lower with rHuPH20 co-administration versus placebo for most device configurations (1 or 2 mL PFS or AI). Auto-injections with versus without rHuPH20 also resulted in reduced swelling firmness and faster swelling resolution over time. Slow injections with rHuPH20 had shorter and more consistent injection time versus placebo. In humans, minimal injection site swelling and negligible back leakage were observed for 2-mL injections of placebo, while more erythema was observed in humans versus miniature pigs. Even at high delivery rates with PFS or AI, the addition of rHuPH20 resulted in improved SC injection performance versus placebo in miniature pigs.

A SUBCUTANEOUS INJECTION ASSAY FOR ANTI-ANDROGENS IN THE CHICK

1962 ◽  
Vol 41 (2) ◽  
pp. 268-273 ◽  
Author(s):  
Ralph I. Dorfman
Keyword(s):  
Dose Response ◽  
Subcutaneous Injection ◽  
Response Relationship ◽  
Dose Response Relationship

ABSTRACT The stimulating action of testosterone on the chick's comb can be inhibited by the subcutaneous injection of 0.1 mg of norethisterone or Ro 2-7239 (2-acetyl-7-oxo-1,2,3,4,4a,4b,5,6,7,9,10,10a-dodecahydrophenanthrene), 0.5 mg of cortisol or progesterone, and by 4.5 mg of Mer-25 (1-(p-2-diethylaminoethoxyphenyl)-1-phenyl-2-p-methoxyphenyl ethanol). No dose response relationship could be established. Norethisterone was the most active anti-androgen by this test.

THE THYMOLYTIC ACTIVITY OF 6- AND 9-HALOCORTICOIDS AND RELATED STEROIDS

1965 ◽  
Vol 49 (2) ◽  
pp. 262-270 ◽  
Author(s):  
Ralph I. Dorfman ◽  
P. G. Holton ◽  
Fred A. Kind
Keyword(s):  
Double Bond ◽  
Subcutaneous Injection ◽  
Fluocinolone Acetonide ◽  
Relative Potency ◽  
Subcutaneous Route ◽  
Adrenalectomized Rats

ABSTRACT Adrenalectomized rats were used for the determination of the relative potency of various 6- and 9-halo substituted corticoids administered subcutaneously or by gavage using thymus weightas the endpoint. By subcutaneous injection, fluocinolone acetonide was the most active corticoid at 700 times that of cortisol. This compound was also the most active corticoid by the gavage route and was judged to be 570 times as active as the standard cortisol. The introduction of the 16,17-acetonide and 16,17-acetone 21-acetate groups into 17α,21-dihydroxy-9α,11β-dichloropregna-1,4-diene-3,20-dione increased the activity by a factor of 42 and 100, respectively. The introduction of the δ1 double bond into 6α-fluoroprogesterone 16,17-acetonide caused an increase of 10-fold in thymolytic activity assessed by the subcutaneous route

QUANTITATIVE RELATIONS IN THE AQUEOUS FLARE RESPONSE INDUCED BY α-MELANOCYTE STIMULATING HORMONE IN THE RABBIT EYES

1965 ◽  
Vol 49 (1) ◽  
pp. 166-176 ◽  
Author(s):  
K. Dyster-Aas ◽  
C. E. T. Krakau
Keyword(s):  
Subcutaneous Injection ◽  
Great Variability ◽  
Local Administration ◽  
Aqueous Flare ◽  
Melanocyte Stimulating Hormone ◽  
Flare Response ◽  
Stimulating Hormone

ABSTRACT The aqueous flare response (AFR) to MSH is induced in an increasing percentage of animals with increasing age. The great variability of the responses and the fact that local administration of MSH is not more efficient with lower doses than by subcutaneous injection indicate that the AFR is a complex result in which general factors play a part. The analysis of the variation of the responses has led to a procedure for testing the effect of different preparations.

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